NCT06818474 · Bernstein Clinical Research Center
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
What this study is about
use of lanadelumab in patients with acquired angioedema
View original scientific description
use of lanadelumab in patients with acquired angioedema
Interventions
BIOLOGICAL
Lanadelumab 300 mg
no other intervention
Primary outcome measures
Primary Objective
Time frame: 12 months
Rate of investigator confirmed AAE attacks during study period, as measured by the ACT. AAE attack will be defined as a unique event during which the study subject will progress from no angioedema to symptoms of angioedema and no further angioedema for 24 hours after resolution of the event with rescu therapy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance)
- historical attack rate of \>= on attack per month prior to starting tranexamic acid (TAA)
Exclusion criteria
- History of anaphylaxis or hypersensitivity to biologics
- History of major systemic disease not well controlled in opinion of the PI
- Women who are pregnant or breast feeding
- Concurrent participation in other clinical trials
- HAE Type 1 or 2 and normal complement HAE
Where
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2025 · Source of record for eligibility and locations